FDA Orders Stronger Warnings on Botox Health Risks

The makers of licensed botulinum toxin products like Botox and Myobloc will need to change their products' labeling to include boxed warnings on serious health problems that can result if the toxin spreads beyond the injection site, under a mandate issued today by the U.S. Food and Drug Administration (FDA).

The FDA order came after reports of adverse health problems and at least one death linked to the use of Botox to treat cerebral palsy and spasticity, which are uses that haven't been approved by the FDA.

Botox is typically injected into the skin or into muscle tissue, and has been approved by the FDA for cosmetic and other uses, including removal of frown lines, treatment of crossed eyes and eyelid twitches, and the prevention of severe underarm sweating. And no definitive health problems have been linked to the toxin spreading via these approved uses, Reuters reports.

According to an FDA Update, a number of pediatric cases in which botulinum toxin was used to treat cerebral palsy resulted in the toxin spreading beyond the injection site, and causing "symptoms including difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression."

The FDA today also sent a letter in response to Public Citizen Health Research Group --which had petitioned the FDA to require stronger warnings on Botox -- and notified the group that its petition was granted "with respect to your request that we require the BLA holders ofbotulinum toxin products to provide additional warnings (including a boxed warning) in product labeling regarding the risk of distant spread of the toxin effects from the site of injection."